{"format":1,"id":"117-hr-1629","congress":117,"number":"H.R. 1629","kind":"bill","group":"bills","title":"Fairness in Orphan Drug Exclusivity Act","title_source":"Short Title(s) as Passed House","official_title":"To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.","titles":[{"type":"Official Title as Introduced","title":"To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes."},{"type":"Short Titles from RFS (Referred to Senate) bill text","title":"Fairness in Orphan Drug Exclusivity Act"},{"type":"Display Title","title":"Fairness in Orphan Drug Exclusivity Act"},{"type":"Short Title(s) as Introduced","title":"Fairness in Orphan Drug Exclusivity Act"},{"type":"Short Title(s) as Passed House","title":"Fairness in Orphan Drug Exclusivity Act"}],"outcome":"passed_house","law_number":null,"introduced":"2021-03-08","chambers":{"house":{"status":"roll_call","date":"2021-05-19","vote":{"id":"117-2021-h150","question":"On Passage","title":"Fairness in Orphan Drug Exclusivity Act","result":"Passed","yea":402,"nay":23,"present":0,"not_voting":4,"source":"https://clerk.house.gov/evs/2021/roll150.xml"}},"senate":{"status":"na","date":null,"vote":null}},"president":{"status":"na","date":null},"vice_president_tie_breaker":null,"latest_action":{"text":"Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.","date":"2021-05-20"},"nominees":null,"amendments":[],"other_votes":[{"chamber":"house","date":"2021-05-11","question":"On Motion to Suspend the Rules and Pass","title":"Fairness in Orphan Drug Exclusivity Act","result":"Failed","yea":250,"nay":168,"present":0,"not_voting":12,"kind":"final_candidate","source":"https://clerk.house.gov/evs/2021/roll134.xml"}],"crs_summary":{"date":"2021-05-19","stage":"Passed House","blocks":[{"k":"h","t":"Fairness in Orphan Drug Exclusivity Act"},{"k":"p","t":"This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats. The sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)"},{"k":"p","t":"Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment."},{"k":"p","t":"When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation."}],"words":212},"summary":{"main_subject":{"text":"Amends the Federal Food, Drug, and Cosmetic Act so that an orphan drug designated because its development costs are not expected to be recovered from U.S. sales keeps exclusive approval or licensure only if its sponsor demonstrates that expectation, taking into account sales within 12 years of first marketing.","cites":[{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}]},"core_areas":["Orphan drug exclusive approval and licensure under section 527 of the Federal Food, Drug, and Cosmetic Act"],"what_it_does":[{"text":"Amends section 527(a) of the Federal Food, Drug, and Cosmetic Act so that its exclusive approval or licensure provision is subject to a new subsection (f) as well as subsection (b).","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}},{"text":"Bars the Secretary from granting, recognizing or applying exclusive approval or licensure for certain designated orphan drugs, and requires revocation of it if already granted, unless the sponsor makes the demonstration the text requires.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}},{"text":"For applications approved or licenses issued after enactment, requires the sponsor to demonstrate that no reasonable expectation existed at approval that U.S. development and availability costs would be recovered from U.S. sales made or reasonably expected within 12 years of first marketing.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}},{"text":"For applications approved or licenses issued on or before enactment, requires the sponsor to make the same demonstration not later than 60 days after the date of enactment.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}},{"text":"Requires the Secretary and the sponsor to consider sales from all drugs developed or marketed by the same sponsor or manufacturer, including a licensor, predecessor in interest or related entity, that are covered by the same section 526 designation.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}},{"text":"Applies the amendments to covered drugs regardless of the dates of their designation, approval or licensure, or grant of exclusive approval or licensure, or of any related request or application.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh#H738B48969A034967A0B3E66A7270D9BC"}}],"unexpected":[],"version":{"type":"Engrossed in House","date":"2021-05-19","rule":"passed","href":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text/eh"},"current":true,"model":"claude-sonnet-5-5","approved":"2026-10-15","approved_by":"checks"},"sources":{"congress_gov":"https://www.congress.gov/bill/117th-congress/house-bill/1629","text":"https://www.congress.gov/bill/117th-congress/house-bill/1629/text"},"card":{"image":"card/item/117-hr-1629.png","v":"670bfeafe15f","alt":"Votes on Record. H.R. 1629, 117th Congress: Fairness in Orphan Drug Exclusivity Act. House: 402 Yea, 23 Nay. Outcome: Passed House, 19 May 2021."}}